All Clinical Trials for Germa-medica

The impact of nesiritide in CHF is unclear, but it is possible that systemic vasodilation
leads to adverse consequences even if the direct renal effects are positive. Therefore, this
study will look at the effects of direct intrarenal administration of nesiritide on GFR and
RPF.

Atherosclerosis (in particular stroke and heart attack) is the most important health issue
in modernized society and high blood pressure is an important predisposing factor.
Hypertensive subjects with other chronic disease such as diabetes mellitus or impaired renal
function are particularly vulnerable to these atherosclerotic complications in spite of
standard antihypertensive therapies.
Danshen and Gegen are commonly used in Chinese materia medica as treatment for cardiac
symptoms and atherosclerosis-related disorders.
The objective of this study is to test Danshen and Gegen as an cardiovascular-protective
adjunctive regimen to prevent high-risk hypertensive cohort from primary atherosclerosis.

This was a randomized, single blind, two-period, two sequence cross-over study under fasting
condition to compare the bioavailability of two glimepiride 4 mg tablet formulations (test
and reference formulations).

Bioequivalence Study of Two Formulations of Perindopril 4 mg Tablet Under Fasting Condition

Completed

Dexa Medica Group

N/A

2008-09-01

The objective of this study was to find out whether the bioavailability of PT Dexa Medica's
formulation of 4 mg perindopril tert-butylamine tablets was equivalent to that of the
innovator's product (Prexum® 4 mg, Servier).

Randomized, open, Phase II-III study, comparative between treatment with CSF-470 vaccine ,
allogeneic, irradiated with BCG and molgramostin (rHuGM-CSF) as adjuvants and interferon
alfa 2b (IFN-alpha2b) treatment , in stages IIB, IIC o III (AJCC) post-surgery cutaneous
melanoma patients. This study has been approved by ANMAT ( Administración Nacional de
Medicamentos, Alimentos y Tecnología Médica (ANMAT)), number 1556/2011 (www.anmat.gov.ar).
The study Institution is Instituto Médico Especializado Alexander Fleming, Ciudad Autónoma
de Buenos Aires, Argentina. The Sponsor is Laboratory Pablo Cassará (LPC, S.R.L.).
Study population include a total of 108 patients (72 patients will receive CSF470 vaccine
and 36 patients will receive alpha IFN-alpha 2b) for a total of 24 months.
CSF-470 treatment will consist of four vaccine doses id injection (three weeks apart), then
one dose every two months for the first year and them every three months for the second
year.
Each vaccine consist of a mixture of 17,6.106 melanoma cells, from four melanoma cell lines,
not genetically modified and lethally irradiated. As adjuvant BCG (120 µg prot) the first
day and rHuGM-CSF (Molgramostim, 400 µg, fractionated in four days doses) will be used.
IFN-alpha 2b treatment will consist of s.c. injection of 10 million units (MU) (5 t/w ) for
four weeks and then 5 MU (3t/w) for 23 months.
Both treatments will also compare quality of life (QOL) and study a possible correlation in
the CSF470 vaccine arm between the induced immune response and clinical outcome

Randomized, open, Phase II-III study, comparative between treatment with CSF-470 vaccine ,
allogeneic, irradiated with BCG and molgramostin (rHuGM-CSF) as adjuvants and interferon
alfa 2b (IFN-alpha2b) treatment , in stages IIB, IIC o III (AJCC) post-surgery cutaneous
melanoma patients. This study has been approved by ANMAT ( Administración Nacional de
Medicamentos, Alimentos y Tecnología Médica (ANMAT)), number 1556/2011 (www.anmat.gov.ar).
The study Institution is Instituto Médico Especializado Alexander Fleming, Ciudad Autónoma
de Buenos Aires, Argentina. The Sponsor is Laboratory Pablo Cassará (LPC, S.R.L.).
Study population include a total of 108 patients (72 patients will receive CSF470 vaccine
and 36 patients will receive alpha IFN-alpha 2b) for a total of 24 months.
CSF-470 treatment will consist of four vaccine doses id injection (three weeks apart), then
one dose every two months for the first year and them every three months for the second
year.
Each vaccine consist of a mixture of 17,6.106 melanoma cells, from four melanoma cell lines,
not genetically modified and lethally irradiated. As adjuvant BCG (120 µg prot) the first
day and rHuGM-CSF (Molgramostim, 400 µg, fractionated in four days doses) will be used.
IFN-alpha 2b treatment will consist of s.c. injection of 10 million units (MU) (5 t/w ) for
four weeks and then 5 MU (3t/w) for 23 months.
Both treatments will also compare quality of life (QOL) and study a possible correlation in
the CSF470 vaccine arm between the induced immune response and clinical outcome

Randomized, open, Phase II-III study, comparative between treatment with CSF-470 vaccine ,
allogeneic, irradiated with BCG and molgramostin (rHuGM-CSF) as adjuvants and interferon
alfa 2b (IFN-alpha2b) treatment , in stages IIB, IIC o III (AJCC) post-surgery cutaneous
melanoma patients. This study has been approved by ANMAT ( Administración Nacional de
Medicamentos, Alimentos y Tecnología Médica (ANMAT)), number 1556/2011 (www.anmat.gov.ar).
The study Institution is Instituto Médico Especializado Alexander Fleming, Ciudad Autónoma
de Buenos Aires, Argentina. The Sponsor is Laboratory Pablo Cassará (LPC, S.R.L.).
Study population include a total of 108 patients (72 patients will receive CSF470 vaccine
and 36 patients will receive alpha IFN-alpha 2b) for a total of 24 months.
CSF-470 treatment will consist of four vaccine doses id injection (three weeks apart), then
one dose every two months for the first year and them every three months for the second
year.
Each vaccine consist of a mixture of 17,6.106 melanoma cells, from four melanoma cell lines,
not genetically modified and lethally irradiated. As adjuvant BCG (120 µg prot) the first
day and rHuGM-CSF (Molgramostim, 400 µg, fractionated in four days doses) will be used.
IFN-alpha 2b treatment will consist of s.c. injection of 10 million units (MU) (5 t/w ) for
four weeks and then 5 MU (3t/w) for 23 months.
Both treatments will also compare quality of life (QOL) and study a possible correlation in
the CSF470 vaccine arm between the induced immune response and clinical outcome

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